[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer (PAZPET-1)
This study is ongoing, but not recruiting participants.
Sponsor:
Imperial College London
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01608009
First received: March 22, 2012
Last updated: February 16, 2016
Last verified: September 2015
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Purpose
The purpose of this study is to assess [18F] -fluciclatide as a biomarker of response to pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel in platinum-resistant ovarian cancer patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Neoplasm |
Drug: Pazopanib and paclitaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1b Exploratory Study of [18F]Fluciclatide-PET as a Marker of Angiogenic Response to Combination Therapy With the Pan-VEGF Inhibitor, Pazopanib, and Weekly Paclitaxel in Platinum Resistant Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by Imperial College London:
Primary Outcome Measures:
- Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant
Secondary Outcome Measures:
- The proportion of women who experience side effects from the combination of paclitaxel and pazopanib [ Time Frame: 12 months ] [ Designated as safety issue: No ]Core study assessments including physical examination, vital signs, ECG, and adverse event reporting
- The proportion of patients responding to combination paclitaxel and pazopanib [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 17 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2016 |
| Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pazopanib and paclitaxel |
Drug: Pazopanib and paclitaxel
Pazopanib 800mg od for 7 days, followed by 18 weeks of combination therapy (paclitaxel 80mg/m2 weekly and pazopanib 800mg od). Following the completion of combination therapy, patients will continue on maintenance pazopanib 800mg od until disease progression.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of relapsed ovarian cancer
- Responded to at least on one line of prior platinum based therapy
- Relapsed within platinum resistant interval (≤6months)
- Eastern Cooperative Oncology Group (ECOG) performance status of <2
- Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥25mm using conventional techniques
-
Satisfactory baseline haematologic and organ function:
- Haematologic: Absolute neutrophil count > or = 1.5 X 10^9/L; Platelets > or = 100 X 10^9/L; Haemoglobin > or = 9g/dL; PT or INR < or = 1.2 x ULN; PTT < or = 1.2 x ULN
- Hepatic: Bilirubin < or = 1.5 X ULN; AST or ALT < or = 2.5 X ULN
- Renal: Serum creatinine < or = 1.5 mg/dL; Or if >1.5 mg/dL, calculated creatinine clearance > or = 50mL/min; UPC <1
Exclusion Criteria:
- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study.
-
Treatment with any of the following anti-cancer therapies:
- radiation therapy 28 days prior to the first dose of pazopanib OR
- surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
- chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
- Treatment with anti-angiogenic therapy
- Presence of gross ascites
- Clinically significant peripheral neuropathy
- Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01608009
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608009
Locations
| United Kingdom | |
| Imperial College Healthcare NHS Trust | |
| London, United Kingdom | |
| Southend University Hospital NHS Foundation Trust | |
| Southend, United Kingdom | |
Sponsors and Collaborators
Imperial College London
GlaxoSmithKline
Investigators
| Study Director: | Rohini Sharma, MD | Imperial College London |
| Principal Investigator: | Timothy Crook, MD | Southend University Hospital NHS Foundation Trust |
More Information
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01608009 History of Changes |
| Other Study ID Numbers: | CRO1627 |
| Study First Received: | March 22, 2012 |
| Last Updated: | February 16, 2016 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Imperial College London:
|
platinum resistant ovarian cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016